BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1651826 · Received April 5, 2010

    Report

    Report Number
    2024168-2010-00695
    Event Type
    Death
    Date Received
    April 5, 2010
    Date of Event
    December 12, 2009
    Report Date
    March 11, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. DEATH AND INFECTION (SEPSIS) ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU); HOWEVER, CARDIAC ARREST AND RESPIRATORY FAILURE ARREST ARE NOT LISTED AS ADVERSE EVENTS IN THE XIENCE V IFU. ALTHOUGH, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN. THE ORDER XIENCE V (P.N. 1009529-23, LOT# UNK) REFERENCED IS BEING REPORTED UNDER THIS SAME MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: SEPSIS, RESPIRATORY AND CARDIAC ARREST, DEATH. ONSET OF ADVERSE EVENT: AFTER THE PROCEDURE. IT WAS REPORTED VIA TRIAL THAT ON (B) (6) 2008, THE PATIENT UNDERWENT STENTING IN THE PREDILATED PROXIMAL RIGHT CORONARY ARTERY WITH ONE XIENCE V STENT AND THE PREDILATED ARTERY IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH XIENCE V STENT. ON (B) (6) 2009, THE PATIENT WAS HOSPITALIZED WITH A SEPTIC SACRAL ULCER AND DEVELOPED RESPIRATORY AND CARDIAC ARREST, WAS GIVEN CPR AND DIED ON (B) (6) 2009. NO AUTOPSY WAS PERFORMED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death| H| L| R (P.N. 1009529-23, LOT# UNK)| STENT: 3.0 X 23 MM XIENCE V